{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 12
    }
  },
  "results": [
    {
      "cfres_id": "222805",
      "product_res_number": "Z-0168-2027",
      "event_date_initiated": "2026-09-02",
      "event_date_posted": "2026-10-15",
      "recall_status": "Open, Classified",
      "res_event_number": "99886",
      "product_code": "OEQ",
      "product_description": "Medline surgical convenience kits labeled as:  CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D",
      "code_info": "UDI/DI 10193489461725 (each) 40193489461726 (case), Lot Numbers:  25LMF813, 25IMF341, 25HBR484, 25FBP179, 25EBJ732, 25DBK745, 25CBK191, 25BBE801, 24LBB945, 24IBT658, 24IBD265, 24GBG100, 24EBC752, 24CBQ893, 24BBJ088, 24ABE008, 23JBA374, 23HBV035, 23GBL681, 23EBK074, 23DBL164, 23DBB447, 23ABV418, 22LBG352, 22IBK243, 22HBX829, 22EBA032, 22DBO915, 22BBR573, 21LBB905, 21IBX719, 21HBG260, 21GBH209, 21DBR261, 21BBJ878.",
      "firm_fei_number": "1417592",
      "recalling_firm": "Medline Industries, LP",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "additional_info_contact": "Haley Barclay\n866-359-1704",
      "reason_for_recall": "Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 9/2/2026 via USPS first class mail and email.  The notice explained the issue, potential risk, and requested the following:  \n\"REQUIRED ACTION:\n1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product.\n2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form.\nWebsite link: https://recalls.medline.com, Recall Reference #: R-26-201-FG, Recall Code: \n3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.\"\nThose consignees who further distributed the product were directed to notify the parties to whom the affected product was distributed.  \nFor questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.",
      "product_quantity": "3125 kits",
      "distribution_pattern": "US Nationwide distribution.",
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        "device_name": "Angiography/Angioplasty Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1650",
        "device_class": "2"
      }
    }
  ]
}